Tundra Gifts: Harvesting Local And Regional Resources To Prevent Obesity Among Alaska Native Children In Remote, Underserved Communities
Primary Purpose
Childhood Obesity
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tundra Gifts
Sponsored by
About this trial
This is an interventional prevention trial for Childhood Obesity focused on measuring Healthy Eating, Alaska Native, Traditional Foods
Eligibility Criteria
Inclusion Criteria:
- 3-5 year old children enrolled in Head Start and their primary caregiver in Yup'ik Alaska Native communities
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Tundra gifts program
Comparison
Arm Description
Outcomes
Primary Outcome Measures
Change in age- and sex-specific BMI percentiles and z-scores
Change in child intake of vegetables and fruit
24-hour recall in combination with a 2-day food record
Change in child intake of vegetables and fruit
Skin carotenoid meter using reflection spectroscopy (veggie-meter)
Change in child intake of sugar sweetened beverages
Hair biomarker of sugar using N and C stable isotope ratios
Change in child intake of sugar sweetened beverages
24-hour recall in combination with a 2-day food record
Change in child screen time
Screen time questionnaire
Change in child physical activity
Physical activity questionnaire
Secondary Outcome Measures
Change in adult attitudes and beliefs around healthy eating and active lifestyle
Attitudes and beliefs questionnaire
Change in adult BMI
Change in adult intake of vegetables and fruit
skin carotenoid meter using reflection spectroscopy (veggie-meter)
Full Information
NCT ID
NCT03986632
First Posted
June 2, 2019
Last Updated
June 12, 2019
Sponsor
University of Alaska Fairbanks
Collaborators
Pacific Institute for Research and Evaluation, University of Alaska Anchorage, State of Alaska Department of Health and Social Services, Grand Valley State University, Alaska Native Tribal Health Consortium
1. Study Identification
Unique Protocol Identification Number
NCT03986632
Brief Title
Tundra Gifts: Harvesting Local And Regional Resources To Prevent Obesity Among Alaska Native Children In Remote, Underserved Communities
Official Title
Tundra Gifts: Harvesting Local And Regional Resources To Prevent Obesity Among Alaska Native Children In Remote, Underserved Communities
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2019 (Anticipated)
Primary Completion Date
May 30, 2022 (Anticipated)
Study Completion Date
May 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alaska Fairbanks
Collaborators
Pacific Institute for Research and Evaluation, University of Alaska Anchorage, State of Alaska Department of Health and Social Services, Grand Valley State University, Alaska Native Tribal Health Consortium
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The long-term goal of this community based participatory research project is to prevent obesity in 3-5 year old Alaska Native children in remote communities.
Investigators will design and evaluate a culturally responsive, home-focused intervention, Tundra Gifts, that links early childhood education programming (i.e. Head Start) and federal food assistance programs (i.e. WIC and SNAP) with primary caregivers to support healthy eating and an active lifestyle using a cluster-randomized design. The intervention integrates behavior change theory with Indigenous traditional knowledge. Primary caregivers will attend monthly interactive education session, receive a monthly gift basket that includes resources and supplies to support behavior change at home and receive ongoing social support through a Facebook site. Investigators will also evaluate key process indicators of Tundra Gifts to understand the impact on outcomes of variations in persons and settings and to enhance the generalizability of findings.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
Keywords
Healthy Eating, Alaska Native, Traditional Foods
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tundra gifts program
Arm Type
Experimental
Arm Title
Comparison
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Tundra Gifts
Intervention Description
Tundra Gifts is a home-focused intervention delivered by community health workers (CHW) that focuses on promoting healthy eating and an active lifestyle among 3-5 year olds through family and community partnerships. Primary caregivers will attend monthly interactive education session, receive a monthly gift basket that includes resources and supplies to support behavior change at home and receive ongoing social support through a Facebook site.
Primary Outcome Measure Information:
Title
Change in age- and sex-specific BMI percentiles and z-scores
Time Frame
twice annually for 3 years
Title
Change in child intake of vegetables and fruit
Description
24-hour recall in combination with a 2-day food record
Time Frame
twice annually for 3 years
Title
Change in child intake of vegetables and fruit
Description
Skin carotenoid meter using reflection spectroscopy (veggie-meter)
Time Frame
twice annually for 3 years
Title
Change in child intake of sugar sweetened beverages
Description
Hair biomarker of sugar using N and C stable isotope ratios
Time Frame
twice annually for 3 years
Title
Change in child intake of sugar sweetened beverages
Description
24-hour recall in combination with a 2-day food record
Time Frame
twice annually for 3 years
Title
Change in child screen time
Description
Screen time questionnaire
Time Frame
twice annually for 3 years
Title
Change in child physical activity
Description
Physical activity questionnaire
Time Frame
twice annually for 3 years
Secondary Outcome Measure Information:
Title
Change in adult attitudes and beliefs around healthy eating and active lifestyle
Description
Attitudes and beliefs questionnaire
Time Frame
twice annually for 3 years
Title
Change in adult BMI
Time Frame
twice annually for 3 years
Title
Change in adult intake of vegetables and fruit
Description
skin carotenoid meter using reflection spectroscopy (veggie-meter)
Time Frame
twice annually for 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
3-5 year old children enrolled in Head Start and their primary caregiver in Yup'ik Alaska Native communities
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea Bersamin, PhD
Phone
(907)474-6129
Email
abersamin@alaska.edu
12. IPD Sharing Statement
Learn more about this trial
Tundra Gifts: Harvesting Local And Regional Resources To Prevent Obesity Among Alaska Native Children In Remote, Underserved Communities
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